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Celularity Announces Positive DMC Safety Review and Continuation of its Phase I/II CYNK-001-COVID-19 Study – PRNewswire

Posted: December 1, 2020 at 12:56 pm

FLORHAM PARK, N.J., Dec. 1, 2020 /PRNewswire/ -- Celularity announced today that the independent Data Monitoring Committee (DMC) completed the first assessment of the ongoing Phase I/II CYNK-001-COVID-19(CYNKCOVID) study (https://clinicaltrials.gov/ct2/show/NCT04365101) with CYNK-001 off-the-shelf, allogeneic, natural killer (NK) cell therapy in adults with COVID-19. The DMC confirmed the absence of dose-limiting toxicities and recommended to move forward with the trial. Additionally, there was no evidence of worsening of inflammatory biomarkers observed. The observed clinical findings justify the continuation of the trial. Enrollment is ongoing in this multi-center clinical study with active sites in Arizona, Arkansas, California, New Jersey, and Washington.

"We are encouraged that an esteemed group of independent experts in COVID-19 and cellular therapy determined that CYNK-001 was safe in the first participants receiving the treatment on the multi-site national study. Our goal now is to rapidly complete enrollment of the study so we can determine the efficacy of this promising treatment for COVID-19 with the epidemic resurging in the United States and few good treatment options for many patients,"said the national PI for the CYNKCOVID clinical trial, Corey Casper, M.D., M.P.H.

"The administration of NK cells may have the potential to both control viral infection while also coordinating a more effective immune response that could lead to strong and lasting protection against viruses. With the increasing incidence of COVID-19 nationwide, Celularity reaffirms our commitment to the development of CYNK-001 as a potential therapeutic treatment for patients with limited treatment options. Through our collaboration with investigators, we anticipate rapid enrollment culminating in the next DMC review of safety and efficacy data," said Robert J. Hariri, M.D., Ph.D., Celularity's Founder, Chairman and Chief Executive Officer.

The Phase I/II CYNK-001-COVID-19 (CYNKCOVID) clinical trial investigating CYNK-001 is continuing to enroll to the next evaluation milestone where the external, independent DMC will review the phase I data for both safety and efficacy. Celularity continues to accumulate safety data on CYNK-001 across a broad platform of programs including COVID-19, as well as hematologic and solid tumor malignancies.

About NK Cells NK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

About CYNK-001 CYNK-001 is an investigational cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

About Celularity Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf allogeneic cellular therapies. Celularity's innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post-partum placenta. Through nature's immunotherapy engine the placenta Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Media Contact Factory PR Email: [emailprotected]

SOURCE Celularity, Inc.

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Cell Therapy: A Potential Treatment for COVID-19? | Roots Analysis – Cheshire Media

Posted: December 1, 2020 at 12:56 pm

With the success of first vaccine to reach phase I clinical trial and turning out to be safe, well-tolerated, and capable of generating an immune response against the virus in humans, a lot of hope has been created with this vaccine. However, the research is still ongoing to develop novel therapeutic treatments that could aid infected patients in the meantime. One such growing area of interest is the use of cell therapy.

Cell Therapy: A Potential Treatment for COVID-19?

Cell therapies represent highly innovative therapeutic approaches that have revolutionized healthcare practices. Several studies from all over the world has proposed stem-cells based therapy, specifically mesenchymal stem cells, as a suitable remedial approach in the treatment of acute respiratory distress syndrome (ARDS), which is the leading cause of death in COVID-19 patients. Even though there are no approved cell therapy-based approaches for the prevention or treatment of COVID 19, however, many clinical trials have begun, and scientists are trying relentlessly to develop a therapeutic to treat this disease.

Companies Engaged in the Manufacturing of Cell Therapies

Presently, over 100 industry players and 60 non-industry players are involved in the manufacturing of cell therapies; of these, 52% have the required capabilities for manufacturing T-cell therapies.

The Key Hubs of Cell Therapy Manufacturing

Majority of the industrial stakeholders (41%) are based in North America, followed by those based in Europe (31%) and the remaining in Asia Pacific. It is worth mentioning that within Asia Pacific, Japan (8) emerged as a popular hub for cell therapy manufacturers.

Demand for Cell Therapies (in terms of number of patients) is Anticipated to Grow at a CAGR of >21%, During 2019-2030

Given that advanced therapeutic medicinal products (ATMPs) is relatively a niche domain, the overall commercial demand for cell therapies is estimated to be more than 18,500 patients in 2019 and this value is likely to grow to close to 0.4 billion patients by 2030.

To get a detailed information on the key players, recent developments, capacity available, demand and the likely market evolution, visit this link

Cell Therapy: A Potential Treatment for COVID-19?

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CAR T-Cell Therapy Creates Opportunities for Individualized Treatment in MCL – OncLive

Posted: December 1, 2020 at 12:56 pm

Treatment decisions in mantle cell lymphoma (MCL) have become more nuanced since the FDA approval of the CAR T-cell therapy brexucabtagene autoleucel (Tecartus) in the relapsed/refractory setting, explained Alan P. Z. Skarbnik, MD.

Previously, the treatment of choice for patients who recurred after high-dose therapy and transplant had been 1 of the 3 FDA-approved BTK inhibitors: ibrutinib (Imbruvica), acalabrutinib (Calquence), and zanubrutinib (Brukinsa). Now, there is a decision-making process between BTK inhibitors and CAR T-cell therapy, which is driven by the time to relapse, disease burden, and overall performance status of the patient.

If a patient recurs 8 or 9 years after transplant and doesnt have a lot of disease, a BTK inhibitor may be a better choice at that point. That way, you can safeguard the risks of CAR T-cell therapy to a later time. I do have a number of patients who have very long remissions or disease control with BTK inhibitors in that setting, said Skarbnik. Patients who recur shortly after transplantation who have larger bulk of disease and are more symptomatic may be better candidates for CAR T-cell therapy.

In an interview with OncLive, Skarbnik, a hematologist/oncologist with Novant Health, discussed the data with available treatment options in relapsed/refractory MCL and shared some of the elements of treatment selection.

OncLive: How do you approach treatment selection among the 3 FDA-approved BTK inhibitors in MCL?

Skarbnik: We have not had a head-to-head comparison trial between the 3 agents. All 3 agents are available and efficacious. All we have are cross-trial comparisons. The duration of response [DOR] in the acalabrutinib trial seems to be longer. However, patients were in earlier lines of therapy; the median number of prior lines of therapy was 2 vs 3 in the ibrutinib trial. That may contribute to the difference in DOR. Zanubrutinib has a very good DOR and depth of response.

All 3 drugs seem to be safe and well tolerated. They have different safety profiles, which is not [to say that] one is better than the other, but [rather] that you have to determine what adverse effects [AEs] will be better tolerated in a particular patient.

There is head-to-head comparison between zanubrutinib and ibrutinib in Waldenstrm macroglobulinemia. In terms of the safety profile, zanubrutinib seems to be better tolerated in that particular trial and in that particular disease. You may extrapolate that to other disease settings, because the mechanism of action of the drugs is the same throughout. The newer second-generation BTK inhibitors may be better tolerated than the first-generation BTK inhibitor ibrutinib, but we cant say that yet with certainty. All 3 drugs are great. [The decision is going to come down to] physicians choice.

How has CAR T-cell therapy affected the paradigm?

Brexucabtagene autoleucel was recently approved in MCL based on data from the ZUMA-2 study, which evaluated this treatment in patients with recurrent, relapsed/refractory MCL who had been previously exposed to BTK inhibitor. However, the approval did not require patients to have been exposed to a BTK inhibitor in the commercial setting. Now, its approved for second-line or [later] use, which is appropriate at this point, because even though BTK inhibitors are a great treatment option for patients with relapsed MCL, the best DOR we have seen so far is close to 26 months, which certainly is not ideal.

We try to treat MCL more aggressively in the frontline setting with high-dose cytarabine-containing induction regimens followed by high-dose chemotherapy and autologous stem cell transplant or rescue. This seems to give patients a longer remission and progression-free survival than other treatment approaches in the frontline setting.

The biggest concern here is for patients who recur shortly after that intensive therapythose with recurrent disease 1 to 3 years after a stem cell transplant. These patients have a higher risk of resistance to second-line therapy, and are at a higher risk of early progression after second-line therapy. The treatment of choice up until now has been BTK inhibitors, which are easy to take and are readily available. The AEs are well tolerated, and [patients] do have a response [to this type of treatment].

The length of response is the issue here. We now have the option of CAR T-cell therapy in that setting. Again, that is going to depend on how soon the patient relapses after transplant and their disease burden. We also have to consider the overall performance status of the patient. Are they going to be a good candidate to withstand the AEs of CAR T-cell therapy, or are they a better candidate for a BTK inhibitor?

We dont have long-term follow-up for the [ZUMA-2] trial yet. The true, long-term effect of CAR T-cell therapy in terms of efficacy and disease is not known yet. We dont know if using CAR T-cell therapy prior to a BTK inhibitor changes the response rate or DOR. We dont have those data. It is something well have to look back at retrospectively and try to compare as best as we can.

Certainly, I would be more inclined to use CAR T-cell therapy in a younger patient who has early recurrence after frontline induction, especially if they undergo transplant, and certainly for those who recur after BTK inhibitors. Very few agents can salvage a patient [after that]. In terms of chemotherapy, [rituximab/bendamustine with low-dose cytarabine] seems to be the chemotherapy regimen that has better response rates in the BTK inhibitorrefractory or relapsed setting. However, CAR T-cell therapy was studied specifically in that setting, so its a good option for those patients.

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Moderna Designed a Covid-19 Vaccine in Just Two Days Thanks to mRNA Technology – The Advocate

Posted: November 30, 2020 at 2:59 pm

Moderna Designed a Covid-19 Vaccine in Just Two Days Thanks to mRNA Technology

As laboratories are working hard to develop a vaccine against COVID-19, it emerged that the American pharmaceutical company Moderna took only two days to design its proposal. The speed of response is a result of the use of new mRNA technology, but how does it work?

What could be the greatest scientific advance of the decade was designed in just 48 hours, according to a New York Times report. Mind you, it took them more than three decades of research to come up with a coronavirus vaccine in record time.

Moderna's vaccine is based on messenger RNA, a piece of ribonucleic acid that carries information about the amino acid sequence of a specific protein from the DNA, where all that information is stored, to the ribosome, where in the cell. the different proteins are synthesized. In simple terms, we can view mRNA as a USB device that cells use to pass information from the computer (DNA) to another device, such as the printer (ribosome).

We just announced an amendment to the current supply agreement with the United Kingdom government for an additional 2 million doses of mRNA-1273, our #mRNA vaccine candidate against COVID-19. Read more: https://t.co/w86xN4ckeN pic.twitter.com/rWIVMbSBHN

As they advanced in the production of synthetic RNA, the scientists wondered if they could modify a cell by infiltrating a chain of ribonucleic acid. Thus, they could trick the ribosomes and make them produce the proteins we want.

In 1990, in the laboratories of the University of Wisconsin, it was possible for the first time to "fool" the ribosomes of mice. That opened the door to make "antibodies to vaccinate against infections, enzymes to reverse rare diseases or growth agents to repair damaged heart tissue," the report explains.

Of course, applying it to a human body was more complicated. For one thing, scientists cannot inject synthetic RNA into cells one by one. On the other hand, supplying large amounts of that RNA in the blood could trigger a very dangerous massive immune response.

In 2005, Katalin Karik and Drew Weissman discovered a way to "disguise" synthetic RNA against the immune system. Thus, the infiltrated chain could travel through the body and enter cells without producing immune reactions. This technology is the basis for two of the most advanced vaccines: Moderna's and Pfizer's.

Innovative technologies like mRNA vaccines, currently being investigated, may be critical in the fight against # COVID19 - watch to learn more. pic.twitter.com/UznqUaSq3X

This is how Moderna's vaccine was scheduled in just two days

At first, Moderna researchers were just looking for a quick way to reprogram adult cells and turn them into stem cells. They soon realized that they had something greater: the power to program the molecular system of cells.

The scientists created a kind of "library" with a set of "coded functional implementations" that allowed them to write and design small genomic programs (the synthetic mRNA) quickly and easily.

To do this, they first had to figure out how ribosomes read and synthesize proteins, as well as learn the "machine language" of mRNA. Then we had to find a way to write the instructions we wanted and "compile" it into synthetic RNA. The biggest proof that they succeeded is their coronavirus vaccine.

On January 10, 2020, the first SARS-CoV-2 genome sequencing was made public. There was the description of the spike protein that, due to its particular characteristics, would be the target of the vaccine. The goal is to get the cells to produce this protein, so the immune system could identify it and generate immunity.

A group of Chinese scientists shared the coronavirus genome on this site on January 10. With this gesture, the race for the vaccine began: it allowed EVERYONE who is now developing vaccines to begin designing them. https://t.co/rAgSCRN0Fx pic.twitter.com/OR42Slbfaw

A group of Chinese scientists shared the coronavirus genome on this site on January 10. With this gesture, the race for the vaccine began: it allowed EVERYONE who is now developing vaccines to begin designing them. https://t.co/rAgSCRN0Fx pic.twitter.com/OR42Slbfaw

- Federico Kukso (@fedkukso) October 5, 2020

It took Moderna just two days to design the RNA instruction that would make cells produce the coronavirus spike protein. However, the difficult part remained and they are still working on: verifying that this masked synthetic mRNA can be delivered safely and efficiently.

Therefore, if Moderna laboratories or Pfizer are successful, their achievement would be greater than preventing COVID-19, which is enough. They would be testing the power of a technology capable of changing medicine and the pharmaceutical industry as we know it.

Moderna's vaccine was 94.5% effective, while Pfizer's is 95%, according to phase 3 results.

See also: Pfizer has already asked the Ministry of Health for authorization to distribute its vaccine in Mexico, confirmed Marcelo Ebrad

Related:50 mil pesos por ver 25 pelculas en 25 das? Ofrecen este trabajo en EUModerna dise vacuna contra el covid-19 en solo dos das gracias a la tecnologa ARNmModerna Designed a Covid-19 Vaccine in Just Two Days Thanks to mRNA Technology

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Coronavirus Updates: The Latest Treatments and Vaccines – GovTech

Posted: November 30, 2020 at 2:59 pm

(TNS) - Scientists at Bay Area universities, laboratories, biotechnology companies and drug manufacturers are fashioning drug concoctions out of blood plasma, chimpanzee viruses and cells taken from bone marrow in the race to rid the world of COVID-19.

The microbial treasure hunt is not just to find a cure which may not be possible but to control the debilitating health problems caused by the coronavirus.

Major progress has been made this year. The antiviral drug remdesivir, produced in Foster City, has improved recovery times, and the steroid dexamethasone has cut the number of deaths in severely ill patients.

What follows is a list of some of the most promising medications and vaccines with ties to the Bay Area:

Antibodies

and Immunity

Mesenchymal stem cells / UCSF and UC Davis Medical Center:

UCSF Dr. Michael Matthay is leading a study of whether a kind of stem cell found in bone marrow can help critically ill patients with severe respiratory failure, known as ARDS. Matthay hopes the stem cells can help reduce the inflammation associated with some of ARDS' most dire respiratory symptoms, and help patients' lungs recover.

In all, 120 patients are being enrolled at UCSF Medical Center, Zuckerberg San Francisco General Hospital, the UC Davis Medical Center in Sacramento and hospitals in Oregon and Texas. He said the trial, which includes a small number of ARDS patients who don't have COVID-19, should have results by summer or fall 2021. So far, 28 patients are enrolled in San Francisco.

Lambda-interferon / Stanford University:

Lambda-interferon is a manufactured version of a naturally occurring protein that had been used to treat hepatitis, and researchers hoped it would help patients in the early stages of COVID-19.

Stanford researchers completed their trial of lambda-interferon and found that it did not boost the immune system response to coronavirus infections.

"That trial did not find any difference in outcomes between the treatment and placebo," said Yvonne Maldonado, chief of pediatric infectious diseases at Lucile Packard Children's Hospital at Stanford, where 120 patients were enrolled in the trial. "It didn't work."

Antiviral drugs

Remdesivir / Gilead Sciences ( Foster City):

Remdesivir, once conceived as a potential treatment for Ebola, was approved by the Food and Drug Administration in October for use on hospitalized COVID-19 patients.

Trademarked under the name Veklury, the drug interferes with the process through which the virus replicates itself. It was one of the drugs given to President Trump and has been used regularly in hospitals under what is known as an emergency use authorization.

It was approved after three clinical trials showed hospitalized coronavirus patients who received remdesivir recovered five days faster on average than those who received a placebo. Patients who required oxygen recovered seven days faster, according to the studies.

Gilead now plans to conduct clinical trials to see how remdesivir works on pediatric patients, from newborns to teenagers, with moderate to severe COVID-19 symptoms. Remdesivir is also being studied with steroids and other drugs to see if it works better as part of a medicinal cocktail. An inhalable form of the drug is also being developed.

Favipiravir / Fujifilm Toyama Chemical ( Stanford University):

This antiviral drug, developed in 2014 by a subsidiary of the Japanese film company to treat influenza, is undergoing numerous clinical studies worldwide, including a trial involving 180 patients at Stanford University.

Stanford epidemiologists are testing favipiravir to see if it prevents the coronavirus from replicating in human cells, halts the shedding of the virus and reduces the severity of infection. Unlike remdesivir, it can be administered orally, so it can be used to treat patients early in the disease, before hospitalization is necessary.

The Stanford study has so far enrolled about 90 patients, who are given the drug within 72 hours of when they were first diagnosed with COVID-19. Half of them get a placebo. People can enroll by emailing treatcovid@stanford.edu.

Monoclonal antibodies

REGN-COV2 / Regeneron Pharmaceuticals / Stanford School of Medicine:

The REGN-COV2 cocktail is the same one Trump received, and Stanford is one of dozens of locations nationwide where clinical trials are being held. Two separate trials are under way at Stanford one for hospitalized patients, the other for outpatients. A third trial is about to begin for people who aren't sick but are in contact with carriers of the virus.

Regeneron halted testing on severely ill patients requiring high-flow oxygen or mechanical ventilation after the independent Data and Safety Monitoring Board determined that the drug was unlikely to help them.

The drug is a combination of two monoclonal antibodies lab-made clones of the antibodies produced naturally in people who have recovered from COVID-19. The antibodies bind to the virus' spike protein and block the virus' ability to enter cells.

Dr. Aruna Subramanian, professor of infectious diseases at Stanford and lead investigator for the inpatient trial, said the 21 hospitalized patients in the study receive a high dose like Trump, a lower dose or a placebo. Subramanian plans to expand the inpatient trial to 45 patients. The outpatient study has enrolled a little more than 40 of the 60 patients researchers intend to sign up.

"There's enough promising evidence that it helps people early in the infection," Subramanian said. "What we don't know is whether it helps people who are pretty sick but not critically ill."

Bamlanivimab / Eli Lilly / Stanford and UCSF:

Stanford and UCSF are testing the Eli Lilly monoclonal antibodies on outpatients after the pharmaceutical company halted trials on hospitalized COVID-19 patients because of adverse results.

Dr. Andra Blomkalns, chair of emergency medicine at Stanford and the lead in the Eli Lilly outpatient trial, said she is now enrolling older people with comorbidities like heart disease, chronic lung disease, a history of strokes and severe obesity shortly after they test positive.

The hypothesis is that the bamlanivimab monotherapy, which is very similar to the Regeneron monoclonals, might work best early in the infection. Although about 400 patients have been enrolled in the Lilly phase 3 trials nationwide, to date fewer than 10 have been enrolled at Stanford and UCSF.

Matthay, who headed up the Lilly monoclonal study with LY-CoV555 at UCSF, said the cancellation of this inpatient trial was disappointing, but "just because this one did not work, doesn't mean another one won't work for hospitalized patients."

Blomkalns said the testing criteria has been changing. She expects the outpatient trial to open soon to adolescents ages 12 and up to determine whether the drug can be used as a preventive.

Designer monoclonal antibodies / Vir Biotechnology, San Francisco:

Scientists at Vir are studying several types of monoclonal antibodies, including a type engineered to activate T cells, which can search out and destroy cells infected with the coronavirus. A study published in the journal Nature in October found that monoclonals, modified to bind with certain receptors, stimulated T cells and improved the human immune response.

"By observing and learning from our body's powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases," said Herbert Virgin, the chief scientific officer at Vir and co-author of the study.

A similarly modified monoclonal antibody, leronlimab, is being studied in coronavirus clinical trials by its Washington state drugmaker, CytoDyn, which has developed drugs to treat HIV. The company's chief medical officer is in San Francisco, and the company that does laboratory tests of leronlimab is in San Carlos.

Anti-inflammatory drugs

Colchicine / UCSF ( San Francisco and New York):

The anti-inflammatory drug commonly used to treat gout flare-ups is being studied by scientists at UCSF and New York University. The drug short-circuits inflammation by decreasing the body's production of certain proteins, and researchers hope that it will reduce lung complications and prevent deaths from COVID-19.

Preliminary results from a clinical trial found that "Colchicine can be effective in reducing systemic symptoms of COVID-19 by inhibiting inflammatory biomarkers."

Selinexor / Kaiser Permanente:

Kaiser hospitals in San Francisco, Oakland and Sacramento are studying selinexor, an anticancer drug that blocks a key protein in the cellular machinery for DNA processing. Preliminary findings during the trials indicated that low doses of selinexor helped hospitalized patients with severe COVID-19. The drug has both antiviral and anti-inflammatory properties, and it's administered orally, according to Kaiser's Dr. Jacek Skarbinski.

Vaccines

VXA-COV2-1 / Vaxart, South San Francisco:

The biotechnology company Vaxart is testing VXA-COV2-1, the only potential vaccine in pill form. It uses the genetic code of the coronavirus to trigger a defensive response in mucous membranes. The hope is that the newly fortified membranes will prevent the virus from entering the body.

"It's the only vaccine (candidate) that activates the first line of defense, which is the mucosa," said Andrei Floroiu, Vaxart's chief executive. He said intravenous vaccines kill the virus after it is inside the body, but this one stops it beforehand.

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Coronavirus Updates: The Latest Treatments and Vaccines - GovTech

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Here are the latest updates on coronavirus treatments and the Moderna, Pfizer and other vaccines – San Francisco Chronicle

Posted: November 30, 2020 at 2:59 pm

Scientists at Bay Area universities, laboratories, biotechnology companies and drug manufacturers are fashioning drug concoctions out of blood plasma, chimpanzee viruses and cells taken from bone marrow in the race to rid the world of COVID-19.

The microbial treasure hunt is not just to find a cure which may not be possible but to control the debilitating health problems caused by the coronavirus.

Major progress has been made this year. The antiviral drug remdesivir, produced in Foster City, has improved recovery times, and the steroid dexamethasone has cut the number of deaths in severely ill patients.

What follows is a list of some of the most promising medications and vaccines with ties to the Bay Area:

Antibodies

and Immunity

Mesenchymal stem cells / UCSF and UC Davis Medical Center:

UCSF Dr. Michael Matthay is leading a study of whether a kind of stem cell found in bone marrow can help critically ill patients with severe respiratory failure, known as ARDS. Matthay hopes the stem cells can help reduce the inflammation associated with some of ARDS most dire respiratory symptoms, and help patients lungs recover.

In all, 120 patients are being enrolled at UCSF Medical Center, Zuckerberg San Francisco General Hospital, the UC Davis Medical Center in Sacramento and hospitals in Oregon and Texas. He said the trial, which includes a small number of ARDS patients who dont have COVID-19, should have results by summer or fall 2021. So far, 28 patients are enrolled in San Francisco.

Lambda-interferon / Stanford University:

Lambda-interferon is a manufactured version of a naturally occurring protein that had been used to treat hepatitis, and researchers hoped it would help patients in the early stages of COVID-19.

Stanford researchers completed their trial of lambda-interferon and found that it did not boost the immune system response to coronavirus infections.

That trial did not find any difference in outcomes between the treatment and placebo, said Yvonne Maldonado, chief of pediatric infectious diseases at Lucile Packard Childrens Hospital at Stanford, where 120 patients were enrolled in the trial. It didnt work.

Antiviral drugs

Remdesivir / Gilead Sciences (Foster City):

Remdesivir, once conceived as a potential treatment for Ebola, was approved by the Food and Drug Administration in October for use on hospitalized COVID-19 patients.

Trademarked under the name Veklury, the drug interferes with the process through which the virus replicates itself. It was one of the drugs given to President Trump and has been used regularly in hospitals under what is known as an emergency use authorization.

It was approved after three clinical trials showed hospitalized coronavirus patients who received remdesivir recovered five days faster on average than those who received a placebo. Patients who required oxygen recovered seven days faster, according to the studies.

Gilead now plans to conduct clinical trials to see how remdesivir works on pediatric patients, from newborns to teenagers, with moderate to severe COVID-19 symptoms. Remdesivir is also being studied with steroids and other drugs to see if it works better as part of a medicinal cocktail. An inhalable form of the drug is also being developed.

Favipiravir / Fujifilm Toyama Chemical (Stanford University):

This antiviral drug, developed in 2014 by a subsidiary of the Japanese film company to treat influenza, is undergoing numerous clinical studies worldwide, including a trial involving 180 patients at Stanford University.

Stanford epidemiologists are testing favipiravir to see if it prevents the coronavirus from replicating in human cells, halts the shedding of the virus and reduces the severity of infection. Unlike remdesivir, it can be administered orally, so it can be used to treat patients early in the disease, before hospitalization is necessary.

The Stanford study has so far enrolled about 90 patients, who are given the drug within 72 hours of when they were first diagnosed with COVID-19. Half of them get a placebo. People can enroll by emailing treatcovid@stanford.edu.

Monoclonal antibodies

REGN-COV2 / Regeneron Pharmaceuticals / Stanford School of Medicine:

The REGN-COV2 cocktail is the same one Trump received, and Stanford is one of dozens of locations nationwide where clinical trials are being held. Two separate trials are under way at Stanford one for hospitalized patients, the other for outpatients. A third trial is about to begin for people who arent sick but are in contact with carriers of the virus.

Regeneron halted testing on severely ill patients requiring high-flow oxygen or mechanical ventilation after the independent Data and Safety Monitoring Board determined that the drug was unlikely to help them.

The drug is a combination of two monoclonal antibodies lab-made clones of the antibodies produced naturally in people who have recovered from COVID-19. The antibodies bind to the virus spike protein and block the virus ability to enter cells.

Dr. Aruna Subramanian, professor of infectious diseases at Stanford and lead investigator for the inpatient trial, said the 21 hospitalized patients in the study receive a high dose like Trump, a lower dose or a placebo. Subramanian plans to expand the inpatient trial to 45 patients. The outpatient study has enrolled a little more than 40 of the 60 patients researchers intend to sign up.

Theres enough promising evidence that it helps people early in the infection, Subramanian said. What we dont know is whether it helps people who are pretty sick but not critically ill.

Bamlanivimab / Eli Lilly / Stanford and UCSF:

Stanford and UCSF are testing the Eli Lilly monoclonal antibodies on outpatients after the pharmaceutical company halted trials on hospitalized COVID-19 patients because of adverse results.

Dr. Andra Blomkalns, chair of emergency medicine at Stanford and the lead in the Eli Lilly outpatient trial, said she is now enrolling older people with comorbidities like heart disease, chronic lung disease, a history of strokes and severe obesity shortly after they test positive.

The hypothesis is that the bamlanivimab monotherapy, which is very similar to the Regeneron monoclonals, might work best early in the infection. Although about 400 patients have been enrolled in the Lilly phase 3 trials nationwide, to date fewer than 10 have been enrolled at Stanford and UCSF.

Matthay, who headed up the Lilly monoclonal study with LY-CoV555 at UCSF, said the cancellation of this inpatient trial was disappointing, but just because this one did not work, doesnt mean another one wont work for hospitalized patients.

Blomkalns said the testing criteria has been changing. She expects the outpatient trial to open soon to adolescents ages 12 and up to determine whether the drug can be used as a preventive.

Designer monoclonal antibodies / Vir Biotechnology, San Francisco:

Scientists at Vir are studying several types of monoclonal antibodies, including a type engineered to activate T cells, which can search out and destroy cells infected with the coronavirus. A study published in the journal Nature in October found that monoclonals, modified to bind with certain receptors, stimulated T cells and improved the human immune response.

By observing and learning from our bodys powerful natural defenses, we have discovered how to maximize the capacity of antibodies through the amplification of key characteristics that may enable more effective treatments for viral diseases, said Herbert Virgin, the chief scientific officer at Vir and co-author of the study.

A similarly modified monoclonal antibody, leronlimab, is being studied in coronavirus clinical trials by its Washington state drugmaker, CytoDyn, which has developed drugs to treat HIV. The companys chief medical officer is in San Francisco, and the company that does laboratory tests of leronlimab is in San Carlos.

Anti-inflammatory drugs

Colchicine / UCSF (San Francisco and New York):

The anti-inflammatory drug commonly used to treat gout flare-ups is being studied by scientists at UCSF and New York University. The drug short-circuits inflammation by decreasing the bodys production of certain proteins, and researchers hope that it will reduce lung complications and prevent deaths from COVID-19.

Preliminary results from a clinical trial found that Colchicine can be effective in reducing systemic symptoms of COVID-19 by inhibiting inflammatory biomarkers.

Selinexor / Kaiser Permanente:

Kaiser hospitals in San Francisco, Oakland and Sacramento are studying selinexor, an anticancer drug that blocks a key protein in the cellular machinery for DNA processing. Preliminary findings during the trials indicated that low doses of selinexor helped hospitalized patients with severe COVID-19. The drug has both antiviral and anti-inflammatory properties, and its administered orally, according to Kaisers Dr. Jacek Skarbinski.

Vaccines

VXA-COV2-1 / Vaxart, South San Francisco:

The biotechnology company Vaxart is testing VXA-COV2-1, the only potential vaccine in pill form. It uses the genetic code of the coronavirus to trigger a defensive response in mucous membranes. The hope is that the newly fortified membranes will prevent the virus from entering the body.

Its the only vaccine (candidate) that activates the first line of defense, which is the mucosa, said Andrei Floroiu, Vaxarts chief executive. He said intravenous vaccines kill the virus after it is inside the body, but this one stops it beforehand.

The drug, which is effective against influenza and norovirus, induced both neutralizing antibodies and T cells during coronavirus drug trials, according to preliminary trial results published in September.

VaxiPatch / Verndari (Napa and UC Davis Medical Center):

A Napa company, Verndari, is studying vaccines for COVID-19 that can be delivered using an adhesive patch. Researchers at UC Davis Medical Center in Sacramento said the patch caused an immune response in preclinical tests.

An October report in the online journal ScienceDirect touted the system, saying it could serve as a shelter in place vaccination strategy, in which vulnerable populations receive delivery at home without needing to engage an already-overtaxed health care infrastructure.

If the vaccine is proven effective and safe, patients could receive it through the mail, according to Dr. Daniel Henderson, Verndaris chief executive officer.

ChAdOx1 / AstraZeneca (UCSF, San Francisco General Hospital, Bridge HIV):

Enrollment is under way at 80 sites in the United States, including three in the Bay Area, for the phase 3 trial of AstraZenecas vaccine, developed by Oxford University from an adenovirus, which typically causes colds in chimpanzees.

At least 1,000 of the 40,000 participants in the phase 3 AstraZeneca trial will be from the Bay Area, including 500 at Sutter Healths East Bay AIDS Center in Oakland, 250 at Zuckerberg San Francisco General Hospital and another 250 at Bridge HIV San Francisco.

An interim analysis of trials in Britain and Brazil showed the vaccine was 90% effective in preventing COVID-19 in 131 patients who got a half-dose of the vaccine by mistake. The vaccine was only 62% effective in people who got a full dose, leading to major questions about the results and how the trial was conducted.

Bay Area trial leaders Dr. Annie Luetkemeyer of UCSF and Dr. Susan Buchbinder, director of Bridge HIV and a UCSF professor of medicine and epidemiology, are hoping future trial results are more clear. Thats because AstraZenecas vaccine is cheaper than those made by its rivals Pfizer and Moderna, whose vaccines were 95% and 94.5% effective in preliminary tests.

The AstraZeneca candidate can also be stored at temperatures between 36 and 46 degrees Fahrenheit, which is orders of magnitude higher than the Pfizer and Moderna vaccines. The Pfizer and Moderna vaccines must be kept at 94 degrees below zero Fahrenheit, colder than many storage facilities can manage.

Johnson & Johnson (Stanford University)

The Johnson & Johnson clinical trials have enrolled 20,000 of the 60,000 volunteers worldwide that officials expect to have signed up by Christmas. That includes 70 people at Stanford.

The vaccine is, like the AstraZeneca version, a chimpanzee adenovirus that was genetically altered so that it carries the RNA of the coronavirus spike protein. The technique inspires the body to produce antibodies that block the protein without causing people to get sick.

Phase 2 studies show that it produces a good immune response and the early results of phase 3 show that its safe, said Dr. Philip Grant, assistant professor of infectious disease at Stanford and leader of the trial.

Grant, who is enrolling about 15 people a day for the trial, said he doesnt expect results on the vaccines effectiveness until sometime in March.

Peter Fimrite is a San Francisco Chronicle staff writer. Email: pfimrite@sfchronicle.com Twitter: @pfimrite

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Here are the latest updates on coronavirus treatments and the Moderna, Pfizer and other vaccines - San Francisco Chronicle

Posted in New York Stem Cells | Comments Off on Here are the latest updates on coronavirus treatments and the Moderna, Pfizer and other vaccines – San Francisco Chronicle

Global Cell Harvesting Market to Reach US$381,4 Million by the Year 2027 – Salamanca Press

Posted: November 30, 2020 at 2:59 pm

NEW YORK, Nov. 25, 2020 /PRNewswire/ --Amid the COVID-19 crisis, the global market for Cell Harvesting estimated at US$233.2 Million in the year 2020, is projected to reach a revised size of US$381.4 Million by 2027, growing at a CAGR of 7.3% over the period 2020-2027.Manual, one of the segments analyzed in the report, is projected to grow at a 7.9% CAGR to reach US$284.4 Million by the end of the analysis period. After an early analysis of the business implications of the pandemic and its induced economic crisis, growth in the Automated segment is readjusted to a revised 5.6% CAGR for the next 7-year period. This segment currently accounts for a 28.3% share of the global Cell Harvesting market.

Read the full report: https://www.reportlinker.com/p05798117/?utm_source=PRN

The U.S. Accounts for Over 30.9% of Global Market Size in 2020, While China is Forecast to Grow at a 10.4% CAGR for the Period of 2020-2027

The Cell Harvesting market in the U.S. is estimated at US$72 Million in the year 2020. The country currently accounts for a 30.86% share in the global market. China, the world second largest economy, is forecast to reach an estimated market size of US$34.9 Million in the year 2027 trailing a CAGR of 10.4% through 2027. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at 6.1% and 7% respectively over the 2020-2027 period. Within Europe, Germany is forecast to grow at approximately 6.6% CAGR while Rest of European market (as defined in the study) will reach US$34.9 Million by the year 2027.We bring years of research experience to this 5th edition of our report. The 226-page report presents concise insights into how the pandemic has impacted production and the buy side for 2020 and 2021. A short-term phased recovery by key geography is also addressed.

Competitors identified in this market include, among others,

Read the full report: https://www.reportlinker.com/p05798117/?utm_source=PRN

I. INTRODUCTION, METHODOLOGY & REPORT SCOPE I-1

II. EXECUTIVE SUMMARY II-1

1. MARKET OVERVIEW II-1Cell Harvesting - A Prelude II-1Impact of Covid-19 and a Looming Global Recession II-1With Stem Cells Holding Potential to Emerge as Savior forHealthcare System Struggling with COVID-19 Crisis, Demand forCell Harvesting to Grow II-1Select Clinical Trials in Progress for MSCs in the Treatment ofCOVID-19 II-2Lack of Antiviral Therapy Brings Spotlight on MSCs as PotentialOption to Treat Severe Cases of COVID-19 II-3Stem Cells Garner Significant Attention amid COVID-19 Crisis II-3Growing R&D Investments & Rising Incidence of Chronic Diseasesto Drive the Global Cell Harvesting Market over the Long-term II-3US Dominates the Global Market, Asia-Pacific to ExperienceLucrative Growth Rate II-4Biopharmaceutical & Biotechnology Firms to Remain Key End-User II-4Remarkable Progress in Stem Cell Research Unleashes UnlimitedAvenues for Regenerative Medicine and Drug Development II-4Drug Development II-5Therapeutic Potential II-5

2. FOCUS ON SELECT PLAYERS II-6Recent Market Activity II-7Innovations and Advancements II-7

3. MARKET TRENDS & DRIVERS II-8Development of Regenerative Medicine Accelerates Demand forCell Harvesting II-8The Use of Mesenchymal Stem Cells in Regenerative Medicine toDrive the Cell Harvesting Market II-8Rise in Volume of Orthopedic Procedures Boosts Prospects forStem Cell, Driving the Cell Harvesting II-9Exhibit 1: Global Orthopedic Surgical Procedure Volume (2010-2020) (in Million) II-11Increasing Demand for Stem Cell Based Bone Grafts: PromisingGrowth Ahead for Cell Harvesting II-11Spectacular Advances in Stem Cell R&D Open New Horizons forRegenerative Medicine II-12Exhibit 2: Global Regenerative Medicines Market by Category(2019): Percentage Breakdown for Biomaterials, Stem CellTherapies and Tissue Engineering II-13Stem Cell Transplants Drive the Demand for Cell Harvesting II-13Rise in Number of Hematopoietic Stem Cell TransplantationProcedures Propels Market Expansion II-15Growing Incidence of Chronic Diseases to Boost the Demand forCell Harvesting II-16Exhibit 3: Global Cancer Incidence: Number of New Cancer Casesin Million for the Years 2018, 2020, 2025, 2030, 2035 and 2040 II-17Exhibit 4: Global Number of New Cancer Cases and Cancer-relatedDeaths by Cancer Site for 2018 II-18Exhibit 5: Number of New Cancer Cases and Deaths (in Million)by Region for 2018 II-19Exhibit 6: Fatalities by Heart Conditions: Estimated PercentageBreakdown for Cardiovascular Disease, Ischemic Heart Disease,Stroke, and Others II-19Exhibit 7: Rising Diabetes Prevalence Presents Opportunity forCell Harvesting: Number of Adults (20-79) with Diabetes (inMillions) by Region for 2017 and 2045 II-20Ageing Demographics to Drive Demand for Stem Cell Banking II-20Global Aging Population Statistics - Opportunity Indicators II-21Exhibit 8: Expanding Elderly Population Worldwide: Breakdown ofNumber of People Aged 65+ Years in Million by GeographicRegion for the Years 2019 and 2030 II-21Exhibit 9: Life Expectancy for Select Countries in Number ofYears: 2019 II-22High Cell Density as Major Bottleneck Leads to Innovative CellHarvesting Methods II-22Advanced Harvesting Systems to Overcome Centrifugation Issues II-23Sophisticated Filters for Filtration Challenges II-23Innovations in Closed Systems Boost Efficiency & Productivityof Cell Harvesting II-23Enhanced Harvesting and Separation of Micro-Carrier Beads II-24

4. GLOBAL MARKET PERSPECTIVE II-25Table 1: World Current & Future Analysis for Cell Harvesting byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-25

Table 2: World Historic Review for Cell Harvesting byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-26

Table 3: World 15-Year Perspective for Cell Harvesting byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld Markets for Years 2012, 2020 & 2027 II-27

Table 4: World Current & Future Analysis for Manual byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-28

Table 5: World Historic Review for Manual by Geographic Region- USA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 II-29

Table 6: World 15-Year Perspective for Manual by GeographicRegion - Percentage Breakdown of Value Sales for USA, Canada,Japan, China, Europe, Asia-Pacific and Rest of World for Years2012, 2020 & 2027 II-30

Table 7: World Current & Future Analysis for Automated byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-31

Table 8: World Historic Review for Automated by GeographicRegion - USA, Canada, Japan, China, Europe, Asia-Pacific andRest of World Markets - Independent Analysis of Annual Sales inUS$ Thousand for Years 2012 through 2019 II-32

Table 9: World 15-Year Perspective for Automated by GeographicRegion - Percentage Breakdown of Value Sales for USA, Canada,Japan, China, Europe, Asia-Pacific and Rest of World for Years2012, 2020 & 2027 II-33

Table 10: World Current & Future Analysis for Peripheral Bloodby Geographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-34

Table 11: World Historic Review for Peripheral Blood byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-35

Table 12: World 15-Year Perspective for Peripheral Blood byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-36

Table 13: World Current & Future Analysis for Bone Marrow byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-37

Table 14: World Historic Review for Bone Marrow by GeographicRegion - USA, Canada, Japan, China, Europe, Asia-Pacific andRest of World Markets - Independent Analysis of Annual Sales inUS$ Thousand for Years 2012 through 2019 II-38

Table 15: World 15-Year Perspective for Bone Marrow byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-39

Table 16: World Current & Future Analysis for Umbilical Cord byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-40

Table 17: World Historic Review for Umbilical Cord byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-41

Table 18: World 15-Year Perspective for Umbilical Cord byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-42

Table 19: World Current & Future Analysis for Adipose Tissue byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-43

Table 20: World Historic Review for Adipose Tissue byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-44

Table 21: World 15-Year Perspective for Adipose Tissue byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-45

Table 22: World Current & Future Analysis for OtherApplications by Geographic Region - USA, Canada, Japan, China,Europe, Asia-Pacific and Rest of World Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2020 through2027 II-46

Table 23: World Historic Review for Other Applications byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-47

Table 24: World 15-Year Perspective for Other Applications byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-48

Table 25: World Current & Future Analysis for Biotech &Biopharma Companies by Geographic Region - USA, Canada, Japan,China, Europe, Asia-Pacific and Rest of World Markets -Independent Analysis of Annual Sales in US$ Thousand for Years2020 through 2027 II-49

Table 26: World Historic Review for Biotech & BiopharmaCompanies by Geographic Region - USA, Canada, Japan, China,Europe, Asia-Pacific and Rest of World Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 II-50

Table 27: World 15-Year Perspective for Biotech & BiopharmaCompanies by Geographic Region - Percentage Breakdown of ValueSales for USA, Canada, Japan, China, Europe, Asia-Pacific andRest of World for Years 2012, 2020 & 2027 II-51

Table 28: World Current & Future Analysis for ResearchInstitutes by Geographic Region - USA, Canada, Japan, China,Europe, Asia-Pacific and Rest of World Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2020 through2027 II-52

Table 29: World Historic Review for Research Institutes byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-53

Table 30: World 15-Year Perspective for Research Institutes byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-54

Table 31: World Current & Future Analysis for Other End-Uses byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2020 through 2027 II-55

Table 32: World Historic Review for Other End-Uses byGeographic Region - USA, Canada, Japan, China, Europe,Asia-Pacific and Rest of World Markets - Independent Analysisof Annual Sales in US$ Thousand for Years 2012 through 2019 II-56

Table 33: World 15-Year Perspective for Other End-Uses byGeographic Region - Percentage Breakdown of Value Sales forUSA, Canada, Japan, China, Europe, Asia-Pacific and Rest ofWorld for Years 2012, 2020 & 2027 II-57

III. MARKET ANALYSIS III-1

GEOGRAPHIC MARKET ANALYSIS III-1

UNITED STATES III-1Increasing Research on Stem Cells for Treating COVID-19 todrive the Cell Harvesting Market III-1Rising Investments in Stem Cell-based Research Favors CellHarvesting Market III-1Exhibit 10: Stem Cell Research Funding in the US (in US$Million) for the Years 2011 through 2017 III-2A Strong Regenerative Medicine Market Drives Cell HarvestingDemand III-2Arthritis III-3Exhibit 11: Percentage of Population Diagnosed with Arthritisby Age Group III-3Rapidly Ageing Population: A Major Driving Demand for CellHarvesting Market III-4Exhibit 12: North American Elderly Population by Age Group(1975-2050) III-4Increasing Incidence of Chronic Diseases Drives Focus onto CellHarvesting III-5Exhibit 13: CVD in the US: Cardiovascular Disease* Prevalencein Adults by Gender & Age Group III-5Rising Cancer Cases Spur Growth in Cell Harvesting Market III-5Exhibit 14: Estimated Number of New Cancer Cases and Deaths inthe US (2019) III-6Exhibit 15: Estimated New Cases of Blood Cancers in the US(2020) - Lymphoma, Leukemia, Myeloma III-7Exhibit 16: Estimated New Cases of Leukemia in the US: 2020 III-7Market Analytics III-8Table 34: USA Current & Future Analysis for Cell Harvesting byType - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-8

Table 35: USA Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-9

Table 36: USA 15-Year Perspective for Cell Harvesting by Type -Percentage Breakdown of Value Sales for Manual and Automatedfor the Years 2012, 2020 & 2027 III-10

Table 37: USA Current & Future Analysis for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-11

Table 38: USA Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-12

Table 39: USA 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-13

Table 40: USA Current & Future Analysis for Cell Harvesting byEnd-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-14

Table 41: USA Historic Review for Cell Harvesting by End-Use -Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-15

Table 42: USA 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-16

CANADA III-17Market Overview III-17Exhibit 17: Number of New Cancer Cases in Canada: 2019 III-17Market Analytics III-18Table 43: Canada Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-18

Table 44: Canada Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-19

Table 45: Canada 15-Year Perspective for Cell Harvesting byType - Percentage Breakdown of Value Sales for Manual andAutomated for the Years 2012, 2020 & 2027 III-20

Table 46: Canada Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-21

Table 47: Canada Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-22

Table 48: Canada 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-23

Table 49: Canada Current & Future Analysis for Cell Harvestingby End-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-24

Table 50: Canada Historic Review for Cell Harvesting by End-Use- Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-25

Table 51: Canada 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-26

JAPAN III-27Increasing Demand for Regenerative Medicine in GeriatricHealthcare and Cancer Care to Drive Demand for Cell Harvesting III-27Exhibit 18: Japanese Population by Age Group (2015 & 2040):Percentage Share Breakdown of Population for 0-14, 15-64 and65 & Above Age Groups III-27Exhibit 19: Cancer Related Incidence and Deaths by Site inJapan: 2018 III-28Market Analytics III-29Table 52: Japan Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-29

Table 53: Japan Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-30

Table 54: Japan 15-Year Perspective for Cell Harvesting by Type- Percentage Breakdown of Value Sales for Manual and Automatedfor the Years 2012, 2020 & 2027 III-31

Table 55: Japan Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-32

Table 56: Japan Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-33

Table 57: Japan 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-34

Table 58: Japan Current & Future Analysis for Cell Harvestingby End-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-35

Table 59: Japan Historic Review for Cell Harvesting by End-Use -Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-36

Table 60: Japan 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-37

CHINA III-38Rising Incidence of Cancer Drives Cell Harvesting Market III-38Exhibit 20: Number of New Cancer Cases Diagnosed (in Thousands)in China: 2018 III-38Market Analytics III-39Table 61: China Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-39

Table 62: China Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-40

Table 63: China 15-Year Perspective for Cell Harvesting by Type -Percentage Breakdown of Value Sales for Manual and Automatedfor the Years 2012, 2020 & 2027 III-41

Table 64: China Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-42

Table 65: China Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-43

Table 66: China 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-44

Table 67: China Current & Future Analysis for Cell Harvestingby End-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-45

Table 68: China Historic Review for Cell Harvesting by End-Use -Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-46

Table 69: China 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-47

EUROPE III-48Cancer in Europe: Key Statistics III-48Exhibit 21: Cancer Incidence in Europe: Number of New CancerCases (in Thousands) by Site for 2018 III-48Ageing Population to Drive Demand for Cell Harvesting Market III-49Exhibit 22: European Population by Age Group (2016, 2030 &2050): Percentage Share Breakdown by Age Group for 0-14, 15-64, and 65 & Above III-49Market Analytics III-50Table 70: Europe Current & Future Analysis for Cell Harvestingby Geographic Region - France, Germany, Italy, UK and Rest ofEurope Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2020 through 2027 III-50

Table 71: Europe Historic Review for Cell Harvesting byGeographic Region - France, Germany, Italy, UK and Rest ofEurope Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-51

Table 72: Europe 15-Year Perspective for Cell Harvesting byGeographic Region - Percentage Breakdown of Value Sales forFrance, Germany, Italy, UK and Rest of Europe Markets for Years2012, 2020 & 2027 III-52

Table 73: Europe Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-53

Table 74: Europe Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-54

Table 75: Europe 15-Year Perspective for Cell Harvesting byType - Percentage Breakdown of Value Sales for Manual andAutomated for the Years 2012, 2020 & 2027 III-55

Table 76: Europe Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-56

Table 77: Europe Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-57

Table 78: Europe 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-58

Table 79: Europe Current & Future Analysis for Cell Harvestingby End-Use - Biotech & Biopharma Companies, Research Institutesand Other End-Uses - Independent Analysis of Annual Sales inUS$ Thousand for the Years 2020 through 2027 III-59

Table 80: Europe Historic Review for Cell Harvesting by End-Use -Biotech & Biopharma Companies, Research Institutes and OtherEnd-Uses Markets - Independent Analysis of Annual Sales in US$Thousand for Years 2012 through 2019 III-60

Table 81: Europe 15-Year Perspective for Cell Harvesting byEnd-Use - Percentage Breakdown of Value Sales for Biotech &Biopharma Companies, Research Institutes and Other End-Uses forthe Years 2012, 2020 & 2027 III-61

FRANCE III-62Table 82: France Current & Future Analysis for Cell Harvestingby Type - Manual and Automated - Independent Analysis of AnnualSales in US$ Thousand for the Years 2020 through 2027 III-62

Table 83: France Historic Review for Cell Harvesting by Type -Manual and Automated Markets - Independent Analysis of AnnualSales in US$ Thousand for Years 2012 through 2019 III-63

Table 84: France 15-Year Perspective for Cell Harvesting byType - Percentage Breakdown of Value Sales for Manual andAutomated for the Years 2012, 2020 & 2027 III-64

Table 85: France Current & Future Analysis for Cell Harvestingby Application - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications - Independent Analysis ofAnnual Sales in US$ Thousand for the Years 2020 through 2027 III-65

Table 86: France Historic Review for Cell Harvesting byApplication - Peripheral Blood, Bone Marrow, Umbilical Cord,Adipose Tissue and Other Applications Markets - IndependentAnalysis of Annual Sales in US$ Thousand for Years 2012 through2019 III-66

Table 87: France 15-Year Perspective for Cell Harvesting byApplication - Percentage Breakdown of Value Sales forPeripheral Blood, Bone Marrow, Umbilical Cord, Adipose Tissueand Other Applications for the Years 2012, 2020 & 2027 III-67

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Global Cell Harvesting Market to Reach US$381,4 Million by the Year 2027 - Salamanca Press

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Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Royal Caribbean, Mesoblast, Loop Industries, and…

Posted: November 30, 2020 at 2:59 pm

NEW YORK, Nov. 24, 2020 (GLOBE NEWSWIRE) -- Bragar Eagel & Squire, P.C., a nationally recognized shareholder rights law firm, reminds investors that class actions have been commenced on behalf of stockholders of Royal Caribbean Group (NYSE: RCL), Mesoblast Limited (NASDAQ: MESO), Loop Industries, Inc. (NASDAQ: LOOP), and Turquoise Hill Resources Ltd. (NYSE: TRQ). Stockholders have until the deadlines below to petition the court to serve as lead plaintiff. Additional information about each case can be found at the link

Royal Caribbean Group (NYSE: RCL)

Class Period: February 4, 2020 to March 17, 2020

Lead Plaintiff Deadline: December 7, 2020

The complaint, filed on October 7, 2020, alleges that throughout the Class Period defendants failed to disclose material facts about the Companys decrease in bookings outside China, instead maintaining that it was only experiencing a slowdown in bookings from China. The Action further alleges that defendants failed to disclose material facts about the Companys inadequate policies and procedures to prevent the spread of COVID-19 on its ships. The truth about the scope of the impact that COVID-19 had on the Companys overall bookings and the inability of Royal Caribbean to prevent the virus spread on its ships was revealed through a series of disclosures.

First, on February 13, 2020, Royal Caribbean issued a press release stating that it had canceled 18 voyages in Southeast Asia due to recent travel restrictions and further warning that recent bookings had been softer for its broader business.

On this news, Royal Caribbean shares fell over 3 percent.

Second, on February 25, 2020, Royal Caribbean filed its 2019 Form 10-K, indicating that COVID-19 concerns were negatively impacting its overall business.

On this news, Royal Caribbean shares fell over 14 percent.

Third, on March 10, 2020, Royal Caribbean withdrew its 2020 financial guidance, increased its revolving credit facility by $550 million, and announced that it would take cost-cutting actions due to the proliferation of COVID-19, further revealing that COVID-19 was severely impacting Royal Caribbeans 2020 customer booking and that its safety measures were inadequate to prevent the spread of the virus on its ships.

On this news, Royal Caribbean shares fell over 14 percent.

Fourth, on March 11, 2020, Royal Caribbeans largest competitor, Carnival, announced a 60-day suspension of all operations, prompting concern that Royal Caribbean would follow suit. At the same time, Royal Caribbean also cancelled two cruises, beginning a series of cancellations and suspensions to follow.

On this news, Royal Caribbean shares fell almost 32 percent.

Fifth, on March 14, 2020, Royal Caribbean announced a suspension of all global cruises for 30 days.

On this news, Royal Caribbean stock fell over 7 percent.

Sixth, on March 16, 2020, the Company revealed that global operations could be suspended longer than anticipated, announcing the cancellations of two additional cruises throughout April and into May.

On this news, Royal Caribbean shares fell over 7 percent.

Finally, on March 18, 2020, analysts downgraded Royal Caribbeans stock and slashed their price targets.

On this news, Royal Caribbean shares fell more than 19 percent.

For more information on the Royal Caribbean class action go to: https://bespc.com/cases/RCL

Mesoblast Limited (NASDAQ: MESO)

Class Period: April 16, 2019 to October 1, 2020

Lead Plaintiff Deadline: December 7, 2020

Mesoblast develops allogeneic cellular medicines using its proprietary mesenchymal lineage cell therapy platform. Its lead product candidate, RYONCIL (remestemcel-L), is an investigational therapy comprising mesenchymal stem cells derived from bone marrow. In February 2018, the Company announced that remestemcel-L met its primary endpoint in a Phase 3 trial to treat children with steroid refractory acute graft versus host disease (aGVHD).

In early 2020, Mesoblast completed its rolling submission of its Biologics License Application (BLA) with the FDA to secure marketing authorization to commercialize remestemcel-L for children with steroid refractory aGVHD.

On August 11, 2020, the FDA released briefing materials for its Oncologic Drugs Advisory Committee (ODAC) meeting to be held on August 13, 2020. Therein, the FDA stated that Mesoblast provided post hoc analyses of other studies to further establish the appropriateness of 45% as the null Day-28 ORR for its primary endpoint. The briefing materials stated that, due to design differences between these historical studies and Mesoblasts submitted study, it is unclear that these study results are relevant to the proposed indication.

On this news, the Companys share price fell $6.09, or approximately 35%, to close at $11.33 per share on August 11, 2020.

On October 1, 2020, Mesoblast disclosed that it had received a Complete Response Letter (CRL) from the FDA regarding its marketing application for remestemcel-L for treatment of SR-aGVHD in pediatric patients. According to the CRL, the FDA recommended that the Company conduct at least one additional randomized, controlled study in adults and/or children to provide further evidence of the effectiveness of remestemcel-L for SR-aGVHD. The CRL also identified a need for further scientific rationale to demonstrate the relationship of potency measurements to the products biologic activity.

On this news, the Companys share price fell $6.56, or 35%, to close at $12.03 per share on October 2, 2020.

The complaint, filed on October 8, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that comparative analyses between Mesoblasts Phase 3 trial and three historical studies did not support the effectiveness of remestemcel-L for steroid refractory aGVHD due to design differences between the four studies; (2) that, as a result, the FDA was reasonably likely to require further clinical studies; (3) that, as a result, the commercialization of remestemcel-L in the U.S. was likely to be delayed; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Mesoblast class action go to: https://bespc.com/cases/MESO

Loop Industries, Inc. (NASDAQ: LOOP)

Class Period: September 24, 2018 to October 12, 2020

Lead Plaintiff Deadline: December 14, 2020

On October 13, 2020, Hindenburg Research published a report alleging, among other things, that Loops scientists, under pressure from CEO Daniel Solomita, were tacitly encouraged to lie about the results of the companys process internally. The report also stated that Loops previous claims of breaking PET down to its base chemicals at a recovery rate of 100% were technically and industrially impossible, according to a former employee. Moreover, the report alleged that Executives from a division of key partner Thyssenkrupp, who Loop entered into a global alliance agreement with in December 2018, told us their partnership is on indefinite hold and that Loop underestimated both costs and complexities of its process.

On this news, the Companys share price fell $3.78, or over 32%, to close at $7.83 per share on October 13, 2020.

The complaint, filed on October 13, 2020, alleges that throughout the Class Period defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Companys business, operations, and prospects. Specifically, defendants failed to disclose to investors: (1) that Loop scientists were encouraged to misrepresent the results of Loops purportedly proprietary process; (2) that Loop did not have the technology to break PET down to its base chemicals at a recovery rate of 100%; (3) that, as a result, the Company was unlikely to realize the purported benefits of Loops announced partnerships with Indorama and Thyssenkrupp; and (4) that, as a result of the foregoing, defendants positive statements about the Companys business, operations, and prospects were materially misleading and/or lacked a reasonable basis.

For more information on the Loop class action go to: https://bespc.com/cases/Loop

Turquoise Hill Resources Ltd. (NYSE: TRQ)

Class Period: July 17, 2018 to July 31, 2019

Lead Plaintiff Deadline: December 14, 2020

Turquoise Hill is an international mining company focused on the operation and development of the Oyu Tolgoi copper-gold mine in Southern Mongolia (Oyu Tolgoi), which is the Companys principal and only material resource property. Turquoise Hills subsidiary, Oyu Tolgoi LLC, holds a 66% interest in Oyu Tolgoi, and the remainder is held by the Government of Mongolia.

Rio Tinto plc and Rio Tinto Limited are operated and managed together as single economic unit and engage in mining and metals operations in approximately 35 countries. Through their subsidiaries, Rio Tinto owns 50.8% of Turquoise Hill. A Rio Tinto subsidiary, Rio Tinto International Holdings, Inc. (Rio Tinto International or RTIH; and collectively with Rio Tinto plc and Rio Tinto Limited, Rio Tinto), is also the manager of the Oyu Tolgoi project, including having responsibility for its development and construction.

On July 31, 2019, Turquoise Hill issued a press release and Management Discussion & Analysis (MD&A) making further disclosures about the status of the project, including that Turquoise Hill took a $600 million impairment charge and a substantial deferred income tax recognition adjustment tied to the Oyu Tolgoi project, and that it suffered a loss in the second quarter. The next day, before the market open, Rio Tinto issued a release concerning in part the project status, including that it had also taken an impairment charge related to the Oyu Tolgoi project, of $800 million.

Following this news, on August 1, 2019, Turquoise Hills common stock price closed at $0.53 per share, down 8.62% from the prior days closing price of $0.58 per share.

The complaint, filed on October 15, 2020, alleges that throughout the Class Period defendants made materially false and misleading statements and omitted to disclose material facts regarding the Companys business and operations. Specifically, defendants made false and or misleading statements and/or failed to disclose that: (i) the progress of underground development of Oyu Tolgoi was not proceeding as planned; (ii) there were significant undisclosed underground stability issues that called into question the design of the mine, the projected cost and timing of production; (iii) the Companys publicly disclosed estimates of the cost, date of completion and dates for production from the underground mine were not achievable; (iv) the development capital required for the underground development of Oyu Tolgoi would cost substantially more than a billion dollars over what the Company had represented; and (v) Turquoise Hill would require additional financing and/or equity to complete the project.

For more information on the Turquoise Hill class action go to: https://bespc.com/cases/TRQ

About Bragar Eagel & Squire, P.C.:Bragar Eagel & Squire, P.C. is a nationally recognized law firm with offices in New York and California. The firm represents individual and institutional investors in commercial, securities, derivative, and other complex litigation in state and federal courts across the country. For more information about the firm, please visit http://www.bespc.com. Attorney advertising. Prior results do not guarantee similar outcomes.

Contact Information:Bragar Eagel & Squire, P.C.Brandon Walker, Esq. Melissa Fortunato, Esq.Marion Passmore, Esq.(212) 355-4648investigations@bespc.comwww.bespc.com

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Bragar Eagel & Squire, PC Reminds Investors That Class Action Lawsuits Have Been Filed Against Royal Caribbean, Mesoblast, Loop Industries, and...

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Stem Cell Therapy Market Research Report Forecast to 2029 (Includes Business Impact of COVID-19) – Cheshire Media

Posted: November 30, 2020 at 2:56 pm

Trusted Business Insights answers what are the scenarios for growth and recovery and whether there will be any lasting structural impact from the unfolding crisis for the Stem Cell Therapy market.

Trusted Business Insights presents an updated and Latest Study on Stem Cell Therapy Market 2020-2029. The report contains market predictions related to market size, revenue, production, CAGR, Consumption, gross margin, price, and other substantial factors. While emphasizing the key driving and restraining forces for this market, the report also offers a complete study of the future trends and developments of the market.The report further elaborates on the micro and macroeconomic aspects including the socio-political landscape that is anticipated to shape the demand of the Stem Cell Therapy market during the forecast period (2020-2029).It also examines the role of the leading market players involved in the industry including their corporate overview, financial summary, and SWOT analysis.

Get Sample Copy of this Report @ Stem Cell Therapy Market Research Report Forecast to 2029 (Includes Business Impact of COVID-19)

Abstract, Snapshot, Market Analysis & Market Definition: Stem Cell Therapy MarketIndustry / Sector Trends

Stem Cell Therapy Market size was valued at USD 7.8 billion in 2018 and is expected to witness 10.2% CAGR from 2019 to 2025.

U.S. Stem Cell Therapy Market Size, By Type, 2018 & 2025 (USD Million)

Rising prevalence of chronic diseases will positively impact the stem cell therapy market growth. Cardiovascular diseases, neurological disorders and other chronic conditions have resulted in high mortality over past few years. Conventional therapeutic methods and treatments are currently replaced due to lack of efficiency and efficacy. Recently developed stem cell therapies are capable of replacing defective cells to treat diseases that has reduced morbidity drastically. Therefore, people have now started relying on stem cell therapy that has long term positive effects.

Advancements in stem cell therapy in developed regions such as North America and Europe have boosted the industry growth. Since past few years, there have been several researches carried out for stem cell therapy. Currently developed stem cell therapies have shown positive outcomes in treatment of leukemia. Similarly, due to advancements in regenerative medicine, several other chronic conditions such as muscular dystrophy and cardiovascular diseases also have been cured. Aforementioned factors have surged the industry growth. However, high cost of allogenic stem cell therapy may hamper the industry growth to some extent.

Market Segmentation, Outlook & Regional Insights: Stem Cell Therapy Market

Stem Cell Therapy Market, By Type

Allogenic stem cell therapy segment held around 39% revenue share in 2018 and it is anticipated to grow substantially during the analysis timeframe. Allogenic stem cell is available as off the shelf therapy and it is easily scalable that helps in providing treatment without delay. Moreover, the procedure includes culturing donor-derived immunocompetent cells that are highly effective in treatment of several diseases. Stem cells obtained in allogenic therapy are free of contaminating tumor cells. This reduces risk for disease recurrence that will surge its demand thereby, stimulating segment growth.

Autologous stem cell therapy segment is estimated to witness 10.1% growth over the forthcoming years. People usually prefer autologous stem cell therapy as it has minimum risk of immunological rejection. However, on introduction of allogenic stem cell therapy, demand for autologous stem cell therapy has declined as it is difficult to scale up. However, there are concerns regarding risk of cross contamination during large scale manufacturing of autologous stem cell lines that will impede segmental growth to some extent.

Stem Cell Therapy Market, By Application

The neurology segment was valued at around USD 1.6 billion in 2018 and it is estimated that it will witness significant growth over the forthcoming years. Stem cells are used to replenish the disrupted neurological cells that help in quick patient recovery. Pluripotent stem cells provide a replacement for cells and tissues to treat Alzheimers, Parkinsons disease, cerebral palsy, amyotrophic lateral sclerosis, and other neurodegenerative diseases. Thus, the pivotal role of stem cells in treating the life-threatening neurological condition will escalate segment growth.

The cardiovascular segment will witness 10% growth over the analysis timeframe. Considerable segmental growth can be attributed to development in stem cell therapies that have enhanced recovery pace in patients suffering from cardiovascular diseases. Recently developed allogeneic stem cell therapies are efficient and easily available that have reduced the mortality rates in cardiovascular patients. Above mentioned factors will propel cardiovascular segment growth in near future.

Stem Cell Therapy Market, By End-users

The hospital segment held over 56% revenue share in 2018 and it is anticipated to grow significantly in near future. The rising preference for stem cell therapies offered by hospitals proves beneficial for business growth. Hospitals have affiliations with research laboratories and academic institutes that carry out research activities for developing stem cell therapies. On the introduction and approval of any novel stem therapy, hospitals implement it immediately. Associations with research and academic institutes further help hospitals to upgrade its stem cell treatment offerings that positively impact the segmental growth.

The clinics segment is expected to grow at around 10% during the forecast timeframe. Clinics specializing in providing stem cell therapies are well-equipped with advanced medical devices and superior quality reagents required for imparting stem cell therapies. However, as clinics offer specialized stem cell therapies, their treatment cost is much higher as compared to hospitals that may reduce its preference.

Stem Cell Therapy Market, By Region

North America stem cell therapy market held around 41.5% revenue share in 2018 and it is estimated to grow substantially in near future. Increasing the adoption of novel stem cell therapies will prove beneficial for regional market growth. Moreover, favorable government initiatives have a positive impact on regional market growth. For instance, the government of Canada has initiated Strategic Innovation Fund Program that invests in research activities carried out for stem cell therapies enabling development in stem cell therapy. Above mentioned factors are expected to drive the North America market growth.

Asia Pacific stem cell therapy market is anticipated to witness 10.8% growth in the near future owing to increasing awareness amongst people pertaining to the benefits of advanced stem cell therapies. Additionally, favorable initiatives undertaken by several organizations will promote industry players to come up with innovative solutions. For instance, according to Pharma Focus Asia, members of the Asia-Pacific Economic Cooperation collaborated with Life Sciences Innovation Forum to involve professionals having expertise in stem cell therapies from academia and research centers to promote developments in stem cell research. Thus, growing initiatives by organizations ensuring the availability of new stem cell therapies will foster regional market growth.

Latin America Stem Cell Therapy Market Size, By Country, 2025 (USD Million)

Key Players, Recent Developments & Sector Viewpoints: Stem Cell Therapy Market

Key industry players in the stem cell therapy market include Astellas Pharma Inc, Cellectis, Celyad, Novadip Biosciences, Gamida Cell, Capricor Therapeutics, Cellular Dynamics, CESCA Therapeutics, DiscGenics, OxStem, Mesoblast Ltd, ReNeuron Group, and Takeda Pharmaceuticals. Chief industry players implement several initiatives such as mergers and acquisitions to sustain market competition. Also, receiving approvals for stem cell therapy products from regulatory authorities fosters the companys growth. For instance, in March 2018, the European Commission approved Takedas Alofisel that is off-the-shelf stem cell therapy. Product approval will help the company to gain a competitive advantage and capture market share.

Stem Cell Therapy Industry Viewpoint

The stem cells industry can be traced back to the 1950s. In 1959 first animals were made by in-vitro fertilization by preserving the stem cells. Till 2000, research was being carried out on stem cells to study its therapeutic effect. In 2000, fund allocations were made to research on cells derived from aborted human fetuses. In the same year, scientists derived human embryonic stem cells from the inner cell mass of blastocytes. Later, in 2010, clinical trials for human embryonic stem cell-based therapy were initiated. As technology progressed, stem cell therapy for treating cancer was developed. However, due to ethical issues, the use of stem cells for curing diseases witnessed slow growth for a few years. But as the regulatory scenario changed, people started preferring stem cell therapies due to its better efficacy. Stem cell therapy is in the developing stage and has numerous growth opportunities in developing economies with a high prevalence of chronic diseases.

Key Industry Development

In September 2020, Takeda Pharmaceutical Company Limited announced the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. The facility provides end-to-end research and development capabilities and will accelerate Takedas efforts to develop next-generation cell therapies, initially focused on oncology with the potential to expand into other therapeutic areas.

The R&D cell therapy manufacturing facility will produce cell therapies for clinical evaluation from discovery through pivotal Phase 2b trials. The current Good Manufacturing Practices (cGMP) facility is designed to meet all U.S., E.U., and Japanese regulatory requirements for cell therapy manufacturing to support Takeda clinical trials around the world.

The proximity and structure of Takedas cell therapy teams allow them to quickly apply what they learn across a diverse portfolio of next-generation cell therapies including CAR NKs, armored CAR-Ts, and gamma delta T cells. Insights gained in manufacturing and clinical development can be quickly shared across global research, manufacturing, and quality teams, a critical ability in their effort to deliver potentially transformative treatments to patients as fast as possible.

Takeda and MD Anderson are developing a potential best-in-class allogeneic cell therapy product (TAK-007), a Phase 1/2 CD19-targeted chimeric antigen receptor-directed natural killer (CAR-NK) cell therapy with the potential for off-the-shelf use being studied in patients with relapsed or refractory non-Hodgkins lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Two additional Phase 1 studies of Takeda cell therapy programs were also recently initiated: 19(T2)28z1xx CAR T cells (TAK-940), a next-generation CAR-T signaling domain developed in partnership with Memorial Sloan Kettering Cancer Center (MSK) to treat relapsed/refractory B-cell cancers, and a cytokine and chemokine armored CAR-T (TAK-102) developed in partnership with Noile-Immune Biotech to treat GPC3-expressing previously treated solid tumors.

Takedas Cell Therapy Translational Engine (CTTE) connects clinical translational science, product design, development, and manufacturing through each phase of research, development, and commercialization. It provides bioengineering, chemistry, manufacturing, and control (CMC), data management, analytical, and clinical and translational capabilities in a single footprint to overcome many of the manufacturing challenges experienced in cell therapy development.

Key Insights Covered: Exhaustive Stem Cell Therapy Market

1. Market size (sales, revenue and growth rate) of Stem Cell Therapy industry.

2. Global major manufacturers operating situation (sales, revenue, growth rate and gross margin) of Stem Cell Therapy industry.

3. SWOT analysis, New Project Investment Feasibility Analysis, Upstream raw materials and manufacturing equipment & Industry chain analysis of Stem Cell Therapy industry.

4. Market size (sales, revenue) forecast by regions and countries from 2019 to 2025 of Stem Cell Therapy industry.

Research Methodology: Stem Cell Therapy Market

Looking for more? Check out our repository for all available reports on Stem Cell Therapy in related sectors.

Quick Read Table of Contents of this Report @ Stem Cell Therapy Market Research Report Forecast to 2029 (Includes Business Impact of COVID-19)

Trusted Business InsightsShelly ArnoldMedia & Marketing ExecutiveEmail Me For Any ClarificationsConnect on LinkedInClick to follow Trusted Business Insights LinkedIn for Market Data and Updates.US: +1 646 568 9797UK: +44 330 808 0580

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Stem Cell Medical Research to Expand in California Following Passage of Prop. 14 – Times of San Diego

Posted: November 30, 2020 at 2:56 pm

Share This Article:A stem cell research center at UC Davis. Courtesy California Institute for Regenerative MedicineBy Barbara Feder Ostrov | CalMatters

Californias stem cell research agency was supposed to be winding down its operations right about now, after a 16-year run and hundreds of millions in grants to scientists researching cutting-edge treatments for diabetes, cancer, Alzheimers and other diseases.

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Instead, the taxpayer-supported California Institute for Regenerative Medicine will get a $5.5 billion reboot after voters earlier this month narrowly passed the Proposition 14bond measure. The overall cost of the bonds with interest will total about $7.8 billion.

Were thrilled that California voters saw fit to continue the work weve done, said Jonathan Thomas, chair of the agencys governing board. California has always had a frontier mentality and a love for the cutting edge, and the work that CIRM has done has put it on the very forefront of regenerative medicine.

Even with Californias economy in a coronavirus-induced tailspin and somescientists arguingthat stem cell research no longer needs taxpayer support,Prop. 14passed with 51 percent of the vote after well-financed supporters pourednearly $21 millioninto the Yes on 14 campaign. The measure was essentially a rerun of Proposition 71, which California voters approved in 2004 after a since-revoked federal ban on embryonic stem cell research.

The cash infusion is expected to keep the institute running for another 10 to 15 years, although the agency will see some significant changes under Prop. 14.

The institute also must contend with longstanding concerns over conflicts of interest that have dogged it since its inception, observers say. About 80% of the money distributed has gone to universities and companies tied to agency board members, according to an analysisby longtime agency watchdog David Jensen, a former Sacramento Bee journalist who runs theCalifornia Stem Cell Reportblog and wrote abookon the institute.

Prop. 14 allows the agency to fund a wider array of research projects even some that dont involve stem cells, but instead are related to genetics, personalized medicine and aging.

Thats necessary because the field has evolved, said Paul Knoepfler, a UC Davis professor of cell biology who studies the role of stem cells in cancer and writes a stem cell blog. He received a 2009 grant from the institute.

Stem cells are interesting and important, but there are going to be a lot of new therapies in the next 10 years that are not stem-cell centric, Knoepfler said.

Other changes for the agency include:

Ysabel Duron, who joined the institutes board late last year, said she sees her role as promoting equity in opportunities for both researchers and patients and ensuring that treatments resulting from the research can benefit all Californians.

Researchers in particular need to boost the diversity of patients in their clinical trials and do a better job communicating the value of their work to the public, Duron said, noting that nearly 40% of Californians are Latino.

We need to keep researchers feet to the fire, said Duron, a former television journalist and founder of the Latino Cancer Institute. They need to show us a plan and we need to reward them.

To date, the agency has funded 64 clinical trials of treatments for many types of cancer, sickle cell disease, spinal cord injuries, diabetes, kidney disease and amyotrophic lateral sclerosis, commonlyknown as Lou Gehrigs disease.But the most advanced trials involve therapies for relatively rare conditions, such asSevere Combined Immunodeficiency known as the bubble baby disease, Jensen noted. That therapy is being reviewed by the FDA but has not yet been approved.

Cancer, heart disease these are the big killers. Thats what most people are interested in, Jensen said. You can fund something for a rare disease, but that doesnt affect the majority of Californians.

And, Jensen asks, what will happen after the agency runs out of money again? Will taxpayers once again be asked to refill its coffers? There was hope when the agency began that revenues from successful treatments would sustain its grant-making in the years to come, but the institute has only received a few hundred thousand dollars, not nearly enough to become self-sustaining without taxpayer support, according to theLegislative Analysts Office.

The sustainability issue is important and its hard to address, Jensen said. The money doesnt last forever.

CalMatters is a public interest journalism venture committed to explaining how Californias state Capitol works and why it matters.

Stem Cell Medical Research to Expand in California Following Passage of Prop. 14 was last modified: November 28th, 2020 by Editor

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Stem Cell Medical Research to Expand in California Following Passage of Prop. 14 - Times of San Diego

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